Duns Number:152165700
Device Description: A reusable handpiece intended for use with Waterlase laser systems in a variety of dental A reusable handpiece intended for use with Waterlase laser systems in a variety of dental hard-tissue and soft-tissue procedures.
Catalog Number
7220003
Brand Name
Waterlase Laser System Gold Straight Handpiece
Version/Model Number
7220003
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K101658
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
4bb23725-de4b-4d09-9725-cf9955296c45
Public Version Date
July 29, 2020
Public Version Number
2
DI Record Publish Date
August 07, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 155 |